Lumafield
Customer Success
DirectorofRegulatoryCompliance&ValidationStrategy
Neural analysis suggests this role is
optimal for Director candidates.
“Director of Regulatory Compliance & Validation Strategy at Lumafield. Skills: Quality Management Systems, Regulatory Compliance, Customer Validation, Audits. Own the QMS. Design QMS”
Industry & Context.
Data-driven insights
What They're Looking For.
Must Have
10+ years of experience, Manage quality systems, ISO 9001 implementation, ISO 17025 implementation, 21 CFR Part 11, Computer Systems Validation, IQ/OQ/PQ, Adapt Lumafield SOPs, Satisfy customer requirements, Translate quality requirements
Nice to Have
Lead Auditor experience, ASQ CQA / CQE certification, FDA 21 CFR Part 820, EU MDR, IATF 16949, AS9100, NADCAP, Industrial CT experience, CMM experience, Dimensional metrology systems, GD&T workflows, Standing up calibration lab, ISO/IEC 17025 scope, Support regulatory filings, Statistical process control, Test method validation/MSA, CAPA, NCMR, PPAP, FAI, Fast-growing hardware/software company
What You'll Do.
Lead compliance initiatives
Prepare for certifications
Demonstrate system robustness
Provide technical documentation
Deliver validated solution
Advise on validated solution
Manage external audits
Manage internal audits
Drive continuous improvement
How You'll Work.
Team & Collaboration
Partner with engineering; Partner with product; Partner with customer success; Partner with sales; Work cross-functionally
Communication Scope
Present system validations
Full Job Description
## What you'll do Own the QMS: Design, implement, and maintain a unified QMS that covers the full scope of Lumafield’s operations, ensuring scalability and adherence to international quality standards. Lead Compliance Initiatives: Lead Lumafield’s compliance program against ISO 9001 (general QMS) and ISO/IEC 17025 (metrology and calibration), and prepare the company for additional certifications as the business expands. Customer Validation: Work directly with enterprise customers to demonstrate the robustness of Lumafield’s systems, providing technical documentation and assurance for their validation processes. Deliver approach for a validated solution: Advise on and provide leadership to Product and Engineering for Lumafield to provide fully validated solutions to our customers in regulated industries Manage External & Internal Audits: Serve as the primary point of contact for customer audits, regulatory body inspections, and internal quality assessments. Act as a Strategic Advisor: Partner with engineering, product, customer success, and sales teams to provide guidance on regulatory requirements and quality assurance best practices. This includes directly working with customers who need to validate Lumafield’s systems inside their own QMS and submissions. Drive Continuous Improvement: Cultivate a culture of continuous improvement across the organization, using data-driven insights to refine processes and mitigate risks. ## About you An Experienced Quality Professional: 10+ years of experience with a proven track record of managing quality systems in highly technical or regulated environments, particularly in medical devices Compliance Expert: You possess deep, hands-on experience navigating and implementing ISO 9001, ISO 17025, and 21 CFR Part 11, Computer Systems Validation (CSV), and IQ/OQ/PQ Understands the Customer: Able to adapt Lumafield SOPs to satisfy customer requirements in Medical Device, Automotive, Aerospace, and Defense sectors. Understands ISO 13485
Applying for this Director of Regulatory Compliance & Validation Strategy role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Lever
- Lever uses a streamlined one-page form — apply in under 5 minutes.
- LinkedIn import works well; review parsed data before submitting.
- The cover letter field is optional but visible to reviewers — use it to differentiate.
- Referral codes from employees can significantly boost visibility of your application.
ANONYMOUS · UNFILTERED
What do employees actually say about Lumafield?
Real rants from real employees. Read before you apply.